Silent brain lesion monitoring after VARIPULSE pulsed field ablation for atrial fibrillation

A Prospective Observational Study Evaluating the Incidence of Silent Cerebral Lesions and Procedural Safety Following Atrial Fibrillation Ablation Using the VARIPULSE™ Pulsed Field Ablation System

We will see if pulsed field ablation with the VARIPULSE system leads to silent brain lesions on MRI in adults treated for paroxysmal or persistent atrial fibrillation.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Seoul National University Hospital (Academic / other)
• Locations: 1 site (Seoul, Jongro-ku)
• Trial ID: NCT07363278 on ClinicalTrials.gov

What this trial studies

This single-arm observational study enrolls adults with paroxysmal or persistent atrial fibrillation who undergo left-atrial ablation using the VARIPULSE pulsed field ablation system. Participants will receive brain MRI (DWI and FLAIR sequences) within 1–3 days after the procedure to detect silent cerebral lesions, and they will complete neurological and cognitive tests to look for subtle functional changes. Lesion characteristics—number, size, location—and total lesion burden will be recorded and compared with historical data from radiofrequency and cryoballoon ablation. Routine clinical follow-up for AF management will continue per institutional standard of care.

Who should consider this trial

Good fit: Adults (≥19 years) with paroxysmal or persistent AF scheduled for left-atrial ablation with the Varipulse PFA catheter who have not had prior AF ablation, recent stroke/TIA, or significant left-ventricular dysfunction are ideal candidates.

Not a fit: Patients excluded by the protocol—such as those under 19, with prior stroke/TIA, recent intracardiac thrombus, recent cardiac surgery or acute coronary syndrome, LVEF <35%, pregnancy, or who require concomitant RF ablation—are unlikely to benefit from the study's findings.

Why it matters

Potential benefit: If PFA shows fewer or smaller silent cerebral lesions than thermal ablation, patients could have a lower long-term risk of cognitive decline and stroke.

How similar studies have performed: Early reports from pulsed field ablation programs suggest lower collateral injury and relatively few silent cerebral lesions compared with thermal techniques, but published evidence is limited and not yet definitive.

Eligibility criteria

Inclusion Criteria:

1\) Patients undergoing atrial fibrillation ablation using the Varipulse™ catheter

Exclusion Criteria:

1. Individuals under 19 years of age
2. Patients who undergo concomitant radiofrequency ablation of the left atrium during the procedure
3. Patients with a history of stroke or transient ischemic attack (TIA)
4. Patients who have previously undergone ablation or surgery for atrial fibrillation
5. Patients with intracardiac thrombus or embolic events within the past 90 days
6. Patients who have experienced cardiac surgery or acute coronary syndrome within the past 90 days
7. Patients with contraindications to oral anticoagulant therapy, or those who require temporary discontinuation of anticoagulation due to procedural complications (e.g., cardiac tamponade)
8. Patients with a left ventricular ejection fraction (LVEF) of less than 35%
9. Women who are currently pregnant or planning to become pregnant during the study period
10. Patients with a life expectancy of less than one year
11. Patients at increased risk during MRI scanning (e.g., those with pacemakers or other metallic implants affected by MRI, or those with severe claustrophobia)

Where this trial is running

Seoul, Jongro-ku

• Seoul National Universtiy Hospital, Seoul — Seoul, Jongro-ku, South Korea (Recruiting)

Study contacts

• Study coordinator: Eue-Keun Choi, MD, PhD

Conditions Atrial Fibrillation; atrial fibrillation; catheter ablation; silent cerebral lesions; pulsed field ablation